Lecture 3 Flashcards
Pharmacy law before 1900
oversight is slim
only law was in 1848 which required US customs inspections to prevent adulterated drugs from entering the country
Harvey Washington Wiley
played a huge role in bringing light to the inclusion of contaminats in food and drugs
3 key roles that led to pure food and drug act
Wiley - known as father of pure food and drug act
great American fraud - article exposed patent drugs
The jungle - exposes the negative aspects of food processing
1906 Pure food and drug act
First law
3 things it did:
Recognized the US pharmacopeia and the national formulary as standard drug references
Defined misbraning and adulteration and assigned penalties to each practice
Established the bureau of chemistry in the US department of agriculture as the responsible party for enforcement - headed by wiley
Renamed as the FDA in 1930
Official Compendia
composed of 3 groups:
1.United states Pharmacopoeia (USP)
- National Formulary (NF)
- Homoeopathic Pharmacopoeia of the United States (HPUS)
Adulteration
Is the product in the bottle what it is inteded to be? If No its adulterated
Product is adulterated if it has the following:
Product contains any poisonous or insanitary ingredients or lacks adequate controls in manufacture.
Strength, quality, or purity differs from the official compendium
Strength differs from representation if not found in official compendium
Product is mixed with another substance to reduce its quality or strength, or substituted altogether
Delayed, denied, or limited inspection, or refusal to permit entry or inspection
Adulteration of Devices
Devices not in conformity with performance standards
Certain class III devices that do not have appropriate approval for use
Banned devices (prosthetic hair fibers, powered gloves)
Manufacture, packing, storage, or instillation of a device not conforming to applicable requirements or conditions
Failure to comply with requirements under which a device was exempted for investigational use
Class I devices
Class I devices: not used for supporting human life and/or preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury
Class II devices:
Class II devices: moderate risk to use, require special controls to assure safety and effectiveness of devices
Class III devices:
Class III devices: high risk to use, support or sustain human life or preventing impairment of human health, and do present a potential unreasonable risk of illness or injury
Misbranding
Generally, is the packaging containing the product (or which must accompany the product) what it is intended to be! If the answer is no, it is misbranded.
Misbranding if the product is any of the following:
Labeling that is false or misleading.
Labeling that does not contain the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or count.
Required information is not prominently displayed or clearly stated.
Established name not included (and at least ½ has large as the proprietary name)
Directions and required warnings not included on label
Not in compliance with official compendia standards for packaging
If the product is liable to deteriorate, unless it is packaged appropriately and notes an expiration date
If the drug container is developed in a misleading way, or is an imitation of another drug
If use of the drug as prescribed is dangerous to health
If an ingredient is a color additive only, and not in compliance labeled appropriately
If advertisements do not include required information
If packaging safety requirements are not met
If a risk evaluation and mitigation strategy (REMS) is required and not appropriately addressed
If a product identifier is required and not included (Rx-Only, Controlled Substance markings, etc.)
Established name
Generic name
Proprietary name
Brand name
Exmaples where drug is adulterated and misbranded
A product is stored outside its recommended temperature (adulterated) leading its label to fall off due to adhesive failure. (misbranding)
An expired drug is counted put into a prescription bottle (adulterated) and then dispensed to a patient (misbranding)
Pure Food and Drug Act Limitations, United States v. Johnson
only prevented false statements on the drug’s identity, and not false or misleading efficacy claims.
The sherley amendment - 1912
Prohibits manufacturers from intentionally misleading claims about a drugs effectiveness.
The onus was on the government to prove intent, which made this amendment extremely difficult to enforce.
Many medications were allowed to remain on the market for years, even those widely known to have false claims and safety risks. - Because government couldn’t really prove that a brand was intentionally lying
1938: Federal Food, Drug, and Cosmetic Act
Permitted FDA control over cosmetics and therapeutic devices
Required new drugs to be shown safe before marketing
Repealed Sherley Amendment requirement to prove intent to defraud in drug misbranding cases
FDA provided safe tolerances be set for unavoidable poisonous substances
Authorized factory inspections:
-Included court injunctions to the FDA tool belt alongside penalties for seizure and prosecutions
-Required selected dangerous drugs to be administered under the direction of a qualified expert (beginning requirement for prescription only medications)
Definition of a Drug: Federal Food, Drug, and Cosmetic Act
Must meet four criteria:
Articles recognized in the official compendia
Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
Articles (other than food) intended to affect the structure or any function of the body of man or other animals
Articles intended for use as a component of any articles specified in (A), (B), or (C)
1950: Alberty Food Products Co. v. United States
The court ruled that “In order for the labeling of a drug to bear “adequate directions for use“… it must, among other things, state the purposes and conditions for which the drug was intended and sufficient information to enable a layman to intelligently and safely attempt self-medication.
1951: Durham-Humphrey Amendment
Amendment was first time we seperated OTC and Legend medications
This amendment also allowed verbal transmission of prescriptions and refills for prescription drugs.
Addressed those medications that were not safe for use except under medical supervision, separating medications into two classes:
Over-the-counter medications could be labeled with “adequate directions for use.”
Legend medications had to be dispensed under the supervision of a health practitioner as a prescription drug and carry the statement “Caution: Federal law prohibits dispensing without a prescription.” So long as prescriber directions were included on the label, this satisfied the adequate directions for use statute.
